NCT02536365

Brief Summary

A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, referred to here as sensory issues. Building on previous work, this study will test the efficacy of Sensory Integration Therapy (SIT), a non-invasive intervention to improve functional skills in children with ASD, in comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A total of 180 children with ASD and sensory issues in the greater New York City Metropolitan area will complete this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

7.1 years

First QC Date

August 27, 2015

Last Update Submit

August 25, 2023

Conditions

Autism

Outcome Measures

Primary Outcomes (2)

  • The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Daily Living

    The PEDI-CAT provides a valid and reliable assessment of the child's ability to perform daily living skills. The psychometric properties including validity and reliability are well documented and the PEDI-CAT showed good discriminant validity between groups of children with and without disabilities in all domains. Score estimates were found to be stable over time with strong test-retest reliability

    Increase between week 0 and week 12 in functional adaptivity as assessed by PEDI-CAT, with follow up for stability of change at week 24

  • The Assessment of Motor and Process Skills (AMPS)

    An observation-based, standardized performance assessment of daily living skills . It has been standardized on more than 150,000 persons, ages 2-100 years of age, internationally and cross-culturally.

    Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24

Secondary Outcomes (1)

  • Repetitive Behavior Scale-Revised (RBS-R)

    Reduction between week 0 and week 12 in repetitive behavior scale score as assessed by RBS-R, with follow up for stability of change at week 24

Study Arms (3)

Sensory Integration Therapy

EXPERIMENTAL

Children receive manualized SIT intervention that follows principles of sensory integration. SIT directly addresses the specific sensory factors hypothesized to underlie the child's functional skills difficulties and follows the Data Driven Decision Making Process, to tailor the intervention to the child's specific sensory issues.

Behavioral: Sensory Integration Therapy

Applied Behavioral Analysis

ACTIVE COMPARATOR

This involves examination of environmental variables that influence behavior and altering those variables to improve the child's skills. Intervention is individualized based on identified needs of the child, assessment of environmental variables impacting their performance of specific functional skills, and their abilities.

Behavioral: Applied Behavioral Analysis

No Treatment

NO INTERVENTION

Treatment as usual will occur through the treatment period. As with the other treatment conditions, the participant agrees to refrain from beginning new treatments during participation in this study.

Interventions

Sensory Integration TherapyBEHAVIORAL

Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.

Sensory Integration Therapy
Applied Behavioral AnalysisBEHAVIORAL

Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.

Applied Behavioral Analysis

Eligibility Criteria

Age6 Years - 114 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 6.0 and 9.5 at the time of enrollment
  • Have a diagnosis of ASD that is confirmed by our research certified licensed psychologist based on clinical impression, DSM-5 criteria, and cut off scores from the Autism Diagnostic Schedule -2 (ADOS) (or CARS; an adjustment made as a consequence of pandemic) and the Autism Diagnostic Interview - Revised (ADI-R)
  • Has a non-verbal cognitive level of 70 or above (IQ cutoff is based on feasibility study data, and we make exceptions on a case-by-case basis to as low as 65)
  • Demonstrate difficulty processing and integrating sensory information as measured by the Sensory Profile (SP; 3 or more subscales or total test score in the definite difference range; or the Sensory Integration and Praxis Test -SIPT-; score of -1.0 on 3 or more subtests)
  • Guardians willing to attend 3 weekly sessions for the duration of the period and to refrain from initiation of any new behavioral, therapeutic or alternative treatments during the study period
  • If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.

You may not qualify if:

  • Children who are receiving \> 12 hours/week of ongoing ASD-related services(excluding their educational programing), or who are receiving more than one hour per week of services that closely approximate the experimental intervention, will be excluded. Additionally, for safety reasons, children with significant medical co-morbidities (e.g., major heart problems, blindness, deafness, cerebral palsy, Fragile X or Down Syndrome, or tuberous sclerosis) will not be allowed to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Specialized Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Schaaf RC, Ridgway EM, Jones EA, Dumont RL, Foxe J, Conly T, Sancimino C, Yi M, Mailloux Z, Hunt JM, Kirschner L, Leiby BE, Molholm S. A Comparative Trial of Occupational Therapy Using Ayres Sensory Integration and Applied Behavior Analysis Interventions for Autistic Children. Autism Res. 2025 Oct;18(10):2120-2134. doi: 10.1002/aur.70099. Epub 2025 Aug 15.

    PMID: 40815044DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sophie Molholm, Ph.D.

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2015

First Posted

August 31, 2015

Study Start

September 1, 2015

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

We will not be sharing IPD

Locations

US(1)